150 mg hard capsule 
rifabutin

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It may harm them, even if they show symptoms similar to yours.

– If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

This leaflet contains information about: 
1. What Ansatipine is and what it is used for 
2. What you need to know before you use Ansatipine 
3. How to use Ansatipine 
4. Possible side effects 
5. How to store Ansatipine 
6. Contents of the packaging and other information 

1. What Ansatipine is and what it is used for

Ansatipine contains an antibiotic, which is effective against infections caused by certain microorganisms and mycobacteria. Ansatipine is used for the treatment of pulmonary tuberculosis and as a preventive measure against infection in AIDSpatients.

2. What you need to know before using Ansatipin

Do not use Ansatipin

  • if you are allergic to rifabutin or any of the other ingredients of this medicine (listed in section 6).
  • if you are being treated with ritonavir.
  • if you have jaundice.

Warnings and cautions

Talk to your doctor before taking Ansatipine:

  • if you have impaired liver or kidney function, especially if concomitant isoniazid treatment is ongoing.

The urine may turn red when you eat Ansatipine. Other body fluids such as coughs, tear fluid and the skin can also turn red. Soft contact lenses can become permanently red.

Diarrhea can occur with the use of almost any antibacterial agent, including Ansatipine. Contact a doctor for diarrhea, even if it occurs after treatment has ended.

Treatment with Ansatipine may affect certain blood tests so that they do not give reliable answers.

Other medicines and Ansatipine

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

The treatment effect may be affected if this medicine is taken at the same time as other medicines.

Tell your doctor if you are taking any of the following medicines before you start taking Ansatipine:

  • HIV medicines (eg amprenavir, phosphamprenavir / ritonavir, indinavir, nelfinavir, saquinavir and lopinavir/ritonavir, tipranavir/ritonavir)
  • certain medicines for fungal infections (eg fluconazole, itraconazole, posaconazole, and voriconazole)
  • certain medicines used to prevent rejection after transplantation (tacrolimus)
  • certain antibiotics (eg clarithromycin)
  • birth control pills

Concomitant use of Ansatipine and oral contraceptives may in some cases cause no effect of oral contraceptives. Therefore, other contraceptives should be used during treatment.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Experience from pregnant women is limited. There is a risk that the fetus will be affected.

Breast-feeding

It is not known if Ansatipine is excreted in human milk.

Driving and using machines

No known effect on the ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention.

One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects.

Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

How to use Ansatipin

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

The usual dose for pulmonary tuberculosis is 150-450 mg (1-3 capsules) for up to 6 months. As a prevention agent for AIDS patients, 300 mg (2 capsules) are normally given once a day. Patients over 70 years of age, patients weighing less than 50 kg, and patients with severe renal impairment receive a lower dose.

If you forget to use Ansatipin

Continue with your usual dosage at the usual time. Do not take a double dose to make up for a forgotten dose. If you are not sure, talk to your doctor or pharmacist

If you stop using Ansatipin

Do not stop taking Ansatipine without talking to your doctor first.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Important information about some side effects:

Ansatipine can affect the white blood cells so that the defense of infection deteriorates. If you get an infection with symptoms such as fever with severe general deterioration or fever with local infection symptoms such as sore throat/pharynx/mouth or urination problems, you should see a doctor as soon as possible so that blood tests can rule out a severe white blood cell deficiency ( agranulocytosis). , occurs in an unknown number of users). It is important that you then information about your medication.

If visual effects or eye symptoms occur during treatment with Ansatipine, an ophthalmologist should be consulted. Particular caution should be exercised with concomitant drug-containing clarithromycin and/or fluconazole and protease inhibitors (which are used for HIV – infection ).

Diarrhea may occur. Contact a doctor for diarrhea, even if it occurs after treatment has ended.

Other side effects that have been reported are:

Very common (may affect more than 1 user in 10 ):

  • Reduction in the number of white blood cells

Common (may affect more than 1 user in 100 ):

  • Anemia ( anemia )
  • rash
  • fever
  • nausea
  • changed taste
  • muscle aches

Uncommon (may affect up to 1 in 100 people):

  • Vomiting
  • changes in the blood that change in the number of blood s
  • joint pain
  • jaundice
  • discoloration of the skin

Has been reported (occurs in an unknown number of users ):

  • liver effects
  • inflammation of the retina
  • hypersensitivity reaction (sometimes severe)
  • spasm of the trachea

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store Ansatipin

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is rifabutin. One capsule contains 150 mg rifabutin.
  • The other ingredients are microcrystalline cellulose, gelatin, sodium lauryl sulfate, magnesium stearate, anhydrous colloidal silica, iron oxide (dye E 172), titanium dioxide (dye E 171).

What the medicine looks like and the contents of the pack

Hard reddish-brown capsules containing a brown, crystalline powder. Blister pack of 30 capsules.

Marketing Authorization Holder and Manufacturer

Pfizer AB

191 90 Sollentuna

Tel: 08-550 520 00

Email: eumedinfo@pfizer.com

Muhammad Nadeem

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